Evaluating Acupuncture Relationship With the Catecholaminergic Pathway

Low Back Pain Clinical Trial

Official title:

Evaluating Acupuncture in the Treatment of Low Back Pain in Athletes and the Relationship With the Catecholaminergic Pathway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876432
• Other study ID #: PEL0011FO
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: February 2017

Study information

• Verified date: July 2018
• Source: Universidad Autónoma Benito Juárez de Oaxaca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Activation of the sympathetic nervous system attenuates inflammation via catecholamines, recent advances in electroacupuncture allow activating critical neuronal networks with the release of catecholamines the aim of this research was to evaluate de effect of electroacupuncture in the activation of sympathetic nervous system and the control of low back pain in athletes

Description:

Activation of the sympathetic nervous system attenuates inflammation via activation of β2-adrenoreceptors by catecholamines, Electrical stimulation of vagus nerve limits the inflammatory response in several animal models of inflammatory diseases, In addition, voluntary activation of the sympathetic nervous system by meditation, training or breathing techniques limits production of proinflammatory cytokines in vivo during experimental endotoxemia in healthy human volunteers.

Currently there are therapies that effectively antagonize proinflammatory cytokines and control pain, as non-steroidal anti-inflammatory drugs and opioid analgesics, but had serious side effects if used chronically. Therefore, alternative therapies as electroacupuncture, which may limit inflammatory cytokine production more physiologically, are warranted. The aim of this study was to evaluate de effect of electroacupuncture used for attenuation of low back pain in the activation of sympathetic nervous system and leukocyte inflammatory potential.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

(Controls)

• Healthy

• Non Smokers

• Athletes

(Cases)

• Acute Low Back Pain (less than 1 month)

• Athletes

• Non Smokers

Exclusion Criteria:

• Sciatic Pain

• Smokers

• Chronic Low Back Pain

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Electroacupuncture
The acupuncture points selected were ST36, BL25, GB30, BL40, GB34 the needles were inserted into acupoints and the depth of needle insertion depended of the acupoints selected to achieve Deqi sensation, which is characterized as a numb, heavy, sore and/or distending sensation. Electrical stimulation was delivered at 4 Hz. The stimulator (ITO EST-160) was then switched on, and the intensity was gradually increased to reach a strong but comfortable level the sensation of EA which is characterized for numbness, tingling and a light muscle cramp. For 15 minutes

Drug:
• Diclofenac sodium
100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days.

Other:
• Sham electroacupuncture
The investigators use 1.0 cm outside point of the real electroacupuncture, the depth of needle insertion was superficial to avoid Deqi sensation, the cables wasn't connected to the electro stimulator and was then switched on for 15 minutes. The participants were threaded separately to avoid sharing experiences about the electroacupuncture sessions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autónoma Benito Juárez de Oaxaca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale	in a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state.; The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks	before Electroacupuncture Time "0"
Primary	Levels of catecholamines in serum	Blood was collected into chilled heparin tubes serum catecholamines were determined by ELISA (Rocky Mountain Diagnostics, Colorado Springs, CO)	five minutes before Electroacupuncture
Secondary	Levels of catecholamines in serum	Blood was collected into chilled heparin tubes serum catecholamines were determined by ELISA (Rocky Mountain Diagnostics, Colorado Springs, CO)	five minutes after Electroacupuncture
Secondary	Visual analogue scale	in a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state.; The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks	Five days after Electroacupuncture